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    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-003367-23
    Sponsor's Protocol Code Number:672-CL-035
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-11-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2005-003367-23
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of YM672 in the Treatment of Painful Bladder Syndrome/Interstitial Cystitis
    A.3.2Name or abbreviated title of the trial where available
    Not available
    A.4.1Sponsor's protocol code number672-CL-035
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot available
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstellas Pharma Europe B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameYM672 (IPD®)
    D.3.2Product code YM672
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSuplatast tosilate
    D.3.9.2Current sponsor codeYM672
    D.3.9.3Other descriptive nameIPD® (Japanese tradename)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Interstitial Cystitis / Painful Bladder Syndrome
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10008928
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of YM672 administered orally in the treatment of painful bladder syndrome (PBS)/interstitial cystitis (IC).
    The primary efficacy endpoint is success, defined as ‘Moderately Improved’ or ‘Markedly Improved’ PBS/IC on the subject-rated 7-point Global Response Assessment (GRA) at the Week 12 and/or End of Treatment (ET) visit.
    E.2.2Secondary objectives of the trial
    Secondary efficacy endpoints include:
    • Global Response Assessment at Weeks 4 and 8
    • Change from baseline to Weeks 4, 8 and 12 in:
    o Symptom Scores according to the IC Symptom Index
    o Problem Scores according to the IC Problem Index
    o Mean number of micturitions per calendar day
    o Mean number of micturitions per night
    o Mean voided volume per micturition
    o Maximum voided volume per micturition
    o Severity of urinary urgency as per a visual analog scale
    o Severity of bladder pain, pelvic pain and pain (including discomfort) accompanied by urinary urgency as per a visual analog scale
    • Response

    Safety assessments include recording and monitoring of vitals signs, physical exams, ECG findings, adverse events as reported by the subject and the investigator, monitoring of hematology and serum chemistry parameters, and urinalysis.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The following must apply for a subject to be randomized into the Study Treatment period:
    NOTE: If the criterion is not specified to be completed at either the Screening or Baseline visit, it should be reviewed/completed at both visits.
    1. Subject has provided written informed consent/authorization prior to any Screening procedures or assessments.
    2. Subject has a diagnosis of PBS/IC, defined as suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and nighttime frequency, in the absence of proven urinary infection or other obvious pathology, with symptoms for at least 12 consecutive weeks prior to the Screening visit.
    3. Subject has a score of at least 1 on the PBS/IC Problem Index, Question #4 (During the past month, how much has the following been a problem for you: Burning pain, discomfort, or pressure in your bladder?) at the Baseline visit.
    4. Subject has a PBS/IC Symptom Index score of at least 7 (total score) at the Baseline visit.
    5. Subject is male or female, ≥18 years of age at the Screening visit.
    6. Subject will, in the opinion of the Investigator or sub-investigator, accurately log/record in their diary.
    7. Female subjects of childbearing potential must be non-lactating, have negative pregnancy tests at the Screening and Baseline visits, and practice effective birth control (in the opinion of the investigator upon consult with each subject) during the study period. Female subjects will be considered of nonchildbearingpotential if they meet one or more of the following criteria:
    • Post menopausal for 2 years (last menstrual period 2 years prior to Screening)
    • Previous history of tubal ligation
    • Previous history of total or subtotal hysterectomy
    8. Subject agrees to comply with study requirements and attend all required study visits.
    9. Subjects using non-opioid analgesics, NSAIDs, antidepressants, antihistamines, anticholinergics, tranquilizers, or treatments (including complementary and alternative treatments) for lower urinary tract symptoms must be on a stable dose of the medication/treatment for at least four weeks prior to the Baseline visit, and should anticipate continuing the medication/treatment at that same stable dose throughout the study.
    E.4Principal exclusion criteria
    Subjects will be excluded from randomization into the Study Treatment period if any of given criteria is true. Subject has:
    - diagnosis suggestive of chronic, severe PBS/IC with continuously present symptoms for the past 6 years prior to the Screening visit.
    - received any intravesicular treatment for PBS/IC, including but not limited to heparin, or dimethyl sulfoxide (DMSO), within 3 months prior to the Screening visit. Subject should have stable symptoms for at least 3 months after the last instillation.
    - undergone cystoscopy or hydrodistention with or without biopsy, within 3 months prior to the Screening visit, or anticipates undergoing either procedure during the study period.
    - taken Elmiron® (pentosan polysulphate sodium) within 6 weeks prior to the Baseline visit, or anticipates taking Elmiron during the course of the study.
    - undergone electric stimulation therapy or urethral dilation within 3 months prior to the Screening visit, or anticipates undergoing electric stimulation therapy or urethral dilation during the study period.
    - has had acupuncture therapy, bladder or prostate biopsy, bladder training, or urodynamics within 1 month prior to the Screening visit, or anticipates having acupuncture therapy, bladder or prostate biopsy, bladder training, or urodynamics during the study period.
    - undergone therapeutic interventions or diagnostic tests that may affect treatment within 3 months prior to the Screening visit, or anticipates undergoing a therapeutic intervention or diagnostic test during the study period.
    - taken systemic steroids or immunomodulators within 4 weeks prior to the Baseline visit, or anticipates taking systemic steroids or immunomodulators during the course of the study.
    - taken opioid analgesics within 4 weeks prior to the Baseline visit, or anticipates taking opioid analgesics during the course of the study.
    - a bladder capacity less than 50 mL at the Baseline visit.
    - greater than 1+ hematuria on dipstick test that has not been fully investigated prior to randomization to exclude significant urological disease. Subjects who are menstruating may be re-screened once menstruation has ceased if they have been found to have hematuria on initial dipstick testing.
    - any clinically relevant abnormality on either of the pre-study physical examinations (Screening and Baseline/Day 1) or on the Screening visit ECG, in the opinion of the investigator.
    - AST, ALT, GGT, or alkaline phosphatase values above the upper limit of normal (ULN) at the Screening visit, or has any other laboratory abnormality at the Screening visit that, in the opinion of the investigator, would contraindicate study participation.
    - not completed the Screening period with acceptable diary compliance, in the opinion of the Investigator, including:
    • the number of voids per day for 7 consecutive days during the Screening period
    • the volume per void for 3 consecutive days during the Screening period.
    - ever been diagnosed with prostate cancer or a bladder tumor.
    - an active urinary tract infection (any positive urine culture with pathogens) including cystitis, pyelonephritis, or urethritis at the Screening visit.
    - chronic prostatitis (bacterial or non-bacterial).
    - active vaginitis at the Baseline visit.
    - active genital herpes.
    - undergone pelvic or peri-pelvic surgery within 6 months prior to the Screening visit.
    - a history of alcoholism.
    - a positive Hepatitis A Immunoglobulin (Ig) M Antibody (Ab), Hepatitis B Surface Antigen (Ag) or Hepatitis C Ab at the Screening visit.
    - cerebrospinal disease or a neurogenic bladder disorder, including CNS disease.
    - cystitis induced by drugs, including cyclophosphamide.
    - been diagnosed with tuberculosis cystitis, BCG-induced cystitis or radiation cystitis.
    - clinically significant urge incontinence or overactive bladder.
    - received any investigational medication within 30 days prior to the Baseline visit, or is scheduled to receive any investigational medication other than YM672 during the course of this study.
    - any medical, physical, mental or behavioral condition that would, in the opinion of the Investigator, preclude the subject from complying with the study regimen.
    - any clinically significant pulmonary, cardiovascular, hepatic, metabolic, renal, gastrointestinal, CNS, or psychiatric disease, infection or any other disease that could compromise subject safety or interfere with the conduct or validity of the study.
    - a hematological or solid malignancy diagnosed within five years prior to the Screening visit, unless subject has received curative treatment and has no evidence of carcinoma and in-situ carcinoma of the cervix, which has been treated, is allowed).
    - been previously exposed to YM672.
    - a known or suspected hype
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is success, defined as "Moderately Improved" or Markedly Improved" PBS/IC on the subject-rated 7-point Global Response Assessment (GRA) at the Week 12 and/or End of Treatment (ET) visit. Success will be analyzed using the Cochran-Mantel-Haenzel test.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    see protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 150
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-04-23
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